FDA.reportPublic FDA data

Modal Total Knee System

Primary DI
B035M311112051
Brand
Modal Total Knee System
Company
MODAL MANUFACTURING LLC
Model
M-3111-1205
Device description
Size 5 Right Femoral Trial CR
Published
2018-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150783000Progressive Orthopaedic Total Knee SystemThe Progressive Orthopaedic Company, LLC2015-06-23JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B035M311112051PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur prosthesis trialA copy of a final femur prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes femoral articulation trials, femoral spacer trials, femoral wedge/augment trials, anterior stop trials, stem adaptor trials, and stem trials. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081983825
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B035M311111011Modal Total Knee SystemM-3111-11012018-04-30
B035M311111021Modal Total Knee SystemM-3111-11022018-04-30
B035M311111031Modal Total Knee SystemM-3111-11032018-04-30
B035M311111041Modal Total Knee SystemM-3111-11042018-04-30
B035M311111051Modal Total Knee SystemM-3111-11052018-04-30
B035M311111061Modal Total Knee SystemM-3111-11062018-04-30
B035M311112011Modal Total Knee SystemM-3111-12012018-04-30
B035M311112021Modal Total Knee SystemM-3111-12022018-04-30
B035M311112031Modal Total Knee SystemM-3111-12032018-04-30
B035M311112041Modal Total Knee SystemM-3111-12042018-04-30
B035M311112061Modal Total Knee SystemM-3111-12062018-04-30
B035M311121011Modal Total Knee SystemM-3111-21012018-04-30
B035M311121021Modal Total Knee SystemM-3111-21022018-04-30
B035M311121031Modal Total Knee SystemM-3111-21032018-04-30
B035M311121041Modal Total Knee SystemM-3111-21042018-04-30
B035M311121051Modal Total Knee SystemM-3111-21052018-04-30
B035M311121061Modal Total Knee SystemM-3111-21062018-04-30
B035M311122011Modal Total Knee SystemM-3111-22012018-04-30
B035M311122021Modal Total Knee SystemM-3111-22022018-04-30
B035M311122031Modal Total Knee SystemM-3111-22032018-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017262819EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262826EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262833EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262840EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262857EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262864EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262871EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262888EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262895EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262901EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262918EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262925EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262932EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262949EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262956EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262963EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262970EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262987EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262994EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263007EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263014EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263021EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263038EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263045EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263052EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263069EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263076EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263083EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263090EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017263106EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10